Research Paper Volume 12, Issue 18 pp 18741—18753
A comprehensive analysis of the fatal toxic effects associated with CD19 CAR-T cell therapy
- 1 Department of Oncology, Xiangya Hospital, Central South University, Changsha 410008, Hunan, China
- 2 Key Laboratory for Molecular Radiation Oncology of Hunan Province, Xiangya Hospital, Central South University, Changsha 410008, Hunan, China
- 3 Department of Life Science, McMaster University, Hamilton, ON L8S 4L8, Canada
- 4 National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha 410008, Hunan, P.R. China
Received: June 16, 2020 Accepted: August 25, 2020 Published: September 24, 2020https://doi.org/10.18632/aging.104058
How to Cite
Copyright: © 2020 Cai et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
To determine the incidence, spectrum, timing, and clinical features of CD19 Chimeric antigen receptor (CAR-T) cell therapy-associated fatal toxic effects. We initiated a comprehensive analysis. First, we retrospectively queried the real-world data from a World Health Organization (WHO) pharmacovigilance database (Vigilyze). Furthermore, we performed a meta-analysis of published trials of CD19 CAR-T cell therapy. From screening the WHO database, we identified 1200 patients: 499 received Kymriah therapy, and 701 received Yescarta therapy. We compared the adverse reactions of the two drugs. We evaluated all published clinical trials, comprising 19 trials and 890 patients. Our meta-analysis showed that the incidence of fatal toxic effects associated with death was 5.4%. Infections and infestations appeared to present the highest risk of death. The toxic effect specific median time to death was 30, 30, and 68 days for total, cytokine release syndrome (CRS), and nervous system disorders (NSD), respectively. We observed a high mortality rate for some toxic effects and an early onset of death with varied causes, indicating the need for clinicians to pay more attention to the monitoring and treatment of these fatal toxic effects when using CD19 CAR-T cell therapy, especially for infections and infestations.